GA 101003666 Start date: 01/04/20 End Date: 31/03/22
Project Title OPENCORONA
WP number,
deliverable number, and Title
WP8 D8.2
Project risk management plan
Responsible partner
name and contact Partner number: 1
Organisation: Karolinska Institutet Name: Hanna Gador
Email: hanna.gador@ki.se Nature
R-Report P-Prototype D-Demonstrator O=-Other
R, Document report
Dissemination level PU-public
PP-restricted to otherprogramme participants RE-restricted to a group of partners CO-only for
consortium members
PU
Delivery Month
Planned M6 – 30 September 2020
Actual delivery date
(dd/mm/yy) 11 November 2020
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 101003666
Ref. Ares(2020)6696741 - 13/11/2020
Description of deliverable
• COMPLETED
• We have created a Project Risk Management Plan togheter with a
monitoring tool for the OPENCORONA consortium in order to monitor the risk manamgent activities and associated communication between partners and the project managment team regarding follow up of both already
foreseen and new risks. They are both available for the consortium at our intra net file sharing tool. The risks will be regularly updated as changes arises, by both the Management team and the participants.
• ANNEXES
Risk Management Plan for the OPENCORONA project
1 This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 101003666
Project Acronym: OPENCORONA
Grant Agreement No: 101003666
Project Duration: 1 April 2020 – 31 March 2022
Responsible Partner: Karolinska Institutet
Name: Hanna Gador E-mail: hanna.gador@ki.se Document version
Version 1 M6
Document History
Version Date Author Description
1.0 October 2020 Hanna Gador Established Plan v1.0
Contents
Executive summary ... 2
Acronyms ... 2
Introduction ... 2
Risk management plan ... 2
Risk assessment: risk identification, categorization and mitigation. ... 2
Continuous risk monitoring ... 2
Overview of times and tasks for risk monitoring ... 3
OPENCORONA overview of risks ... 3
Risk Management Plan
Executive summary
The performance of a project can be impacted by risks and opportunities that is presented at the start of the project as well as throughout the project’s life. To identify, monitor and mitigate risks as well as opportunities through the project is therefor of importance.
The risk and management plan is established according to the OPENCORONA project Grant Agreement no 101003666 WP8 in order to provide a plan for the threats and opportunities that might impact the project performance.
The performance of a project can be impacted by risks and opportunities that is presented at the start of the project as well as throughout the project’s life. To identify, monitor and mitigate risks as well as opportunities through the project is therefor of importance.
Acronyms
OPENCORONA Rapid therapy development through Open nCoronavirus Vaccine Platform
GA Grant Agreement No 101003666
WP Work Package according to Grant agreement Annex 1
PSM Project Steering Committee
PC Project Coordinator
PMO Project Management Office, the coordinators management team
Introduction
The aim of this plan is to encourage project participants to openly communicate risks within the consortium and to find a mitigation strategy to decrease negative impact of the project. The aim of the plan is to encourage all participants to report any risks so that they can be identified, categorized, monitored, and develop appropriate responses together with the WP leaders and PMO.
Annex 1 provides a detailed risk register including information on risk likelihood and impact.
Risk management plan
Risk assessment: risk identification, categorization and mitigation.
The regular risk assessment will be led by the WP leader in communication and encouragement by PC and PMO. The PMO will collect and compile all input received from WP leaders. The risk
assessment will be performed throughout the project and risks will be escalated to the PSC meetings for a broader discussion and assessment.
Continuous risk monitoring
WP leaders will be encouraged by PC and the PMO to update the risk register. The participants has access through the internal tool OPENCORONA Box our monitoring document “OPENCORONA Critical Implementation risks and mitigation actions”. The PMO will continue to discuss the risk monitoring as a recurring agenda item during their meetings as well as during the PSM:s.
3 This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 101003666
The PMO will report, follow up and correspond mitigation strategies to the consortium at regular timepoints or as they arise.
Overview of times and tasks for risk monitoring
Continuous risk monitoring Request from Request to Timeline
Request each WP leader to update the risk register in view of
logged risks and identify new risks PMO WP Leader Prior to meetings,
and/or as the issues arise
Finalize updated risk register PMO n.a. As they arise
Reporting to PSC n.a. PMO, WP
Leaders At every PSC meeting
Report to EC n.a. PMO
At reporting periods, project meetings and as
required
Discuss risk monitoring PMO n.a. As recurring PMO
discussion point.
OPENCORONA overview of risks
OPENCORONA Critical Implementation risks and mitigation actions
Risk
number Description of
risk Level of risk WP
Number
Proposed risk- mitigation
measures Updated
risk level Impact Reason for update
Updated by and when
1 Vaccine candidate not immunogenic Low
WP1, WP2, WP3, WP4, WP5, WP6, WP7, WP8
Several vaccine candidates generated and tested, delivery optimisation
2
Vaccine candidate causes cytokine storm
Medium WP2, WP3, WP4, WP5, WP6, WP7, WP8
Several vaccine candidates generated and tested
3
The vaccine candidate does not protect the challange mice
Low
WP3, WP4, WP5, WP6, WP7, WP8
Several parallel vaccine concept will be
developed by WP1
4 In vivo EP not tolerable Low
WP4, WP5, WP6, WP7, WP8
Cliniporator has been used extensively in clinical practice, extensive experience,
adjust pulse patterns
5 Plasmid can not
grow Low
WP5, WP6, WP7, WP8
Several vaccine candidates generated and tested
6 Plasmid toxic Low WP6, WP7, WP8
Several vaccine candidates generated and tested
7
Study not approved by ethics committee or MPA/EMA
Low WP7
Earlry contacts and Scientific advice with MPA/
EMA
8 Clinical trial fails to show
safety Low WP7
All vaccine candidates are analysed for toxicological effects in vitro and in vivo in animal models.
Toxicologial studies are performed according to GLP and all data is analyzed by the Swedish MPA/EMA before approval of the
clinical trial.
9 Clinical trial fails to show
immunogenicity Medium WP7
The selection of the vaccine candidate is done in the best animal models. The immunogenicity is thoroughly evaluated in larger animals such as rabbits. Only highly immunogenic candidates are evaluated further.
